Single-Use Flexible Cystoscope

K221580 · Hunan Vathin Medical Instrument Co., Ltd. · FAJ · Nov 18, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221580
• Device Name: Single-Use Flexible Cystoscope
• Applicant: Hunan Vathin Medical Instrument Co., Ltd.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

Device Story

Single-use flexible cystoscope; used with Vathin Display Unit and endotherapy accessories. Device captures visual images of adult bladder; transmits data to display unit for clinician visualization. Enables irrigation and treatment procedures. Operated by clinicians in clinical settings. Provides real-time endoscopic visualization to assist in diagnosis and therapeutic interventions. Single-use design eliminates reprocessing requirements; reduces cross-contamination risk.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1:2018 (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity). Electrical safety and EMC testing per IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Performance testing included optical quality (resolution, field of view, depth of field, distortion, SNR), mechanical integrity (bending, air/water tightness), and functional capabilities (suction, irrigation, LED performance).

Technological Characteristics

Single-use flexible endoscope. Digital video technology with LED illumination. Features include irrigation channel, handle-based camera controls, and rotating sleeve. Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Biocompatible materials per ISO 10993-1. Delivered sterile.

Indications for Use

Indicated for endoscopy and treatment of the adult bladder.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Ambu AScope 4 Cysto (K193095)

Submission Summary (Full Text)

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November 17, 2022

Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager, RA Department 1/F, Building 12, Innovation and Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, Hunan 411100 CHINA

Re: K221580

Trade/Device Name: Single-Use Flexible Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: October 19, 2022 Received: October 19, 2022

Dear Du Jing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221580

Device Name Single-use Flexible Cystoscope

Indications for Use (Describe)

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5 510(k) summary

#### ll Submitter

| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. |
|-------------------|-----------------------------------------------------------|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service |
| | Center, No 9 Chuanqi west road, Jiuhua Economic |
| | Development Zone, 411100 Xiangtan, Hunan, China |
| Contact person: | Du Jing |
| | Title: RA Manager |
| | Phone: [phone] |
| | E-mail: [e-mail] |

#### II Device

Trade Name of Device: Single-Use Flexible Cystoscope Common name: Cystoscope and Accessories, Flexible/rigid Classification: Class II, 21 CFR 876.1500 Product Code: FAJ Review Panel: Gastroenterology/Urology

#### III Predicate Device

| Trade name: | Ambu AScope 4 Cysto |
|--------------------|--------------------------------------------|
| Regulation number: | 21 CFR 876.1500 |
| Regulation name: | Cystoscope and Accessories, Flexible/rigid |
| Regulatory class: | Class II |
| Product code: | FAJ |
| Submitter: | Ambu A/S |
| 510(k) number: | K193095 |

#### IV Device description

The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.

#### V Indications for use

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

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# VI Comparison of technological characteristics with the predicate devices

The Single-Use Flexible Cystoscope is similar to the predicate device in the following areas:

- Intended use (including application field, intended user and patient population) .
- Principal operation .
- . Design and performance specifications
- Digital video technology and illumination source .
- It allows for irrigation .
- It is single-use and delivered sterile .

The Single-Use Flexible Cystoscope is different to the predicate device in the following areas:

- The bending angle is larger than the predicate .
- There are 10 specifications while predicate device has 1 specification .
- Working length is 450mm while working length of predicate device is 390mm .

The differences between the Single-Use Flexible Cystoscope and predicate device do not alter suitability of the proposed device for its intended use.

# VII Summary of Non-clinical tests:

# Biocompatibility testing

Biocompatibility of the Single-Use Flexible Cystoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Single-Use Flexible Cystoscope. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

# Performance Testing

The following performance testing was conducted on the Single-Use Flexible Cystoscope:

- Appearance
- . Working length
- Work channel ID ●
- Head OD .

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- Outer diameter of main hose ●
- . Maximum outer diameter of the insertion part
- . Bending angle
- Product weight .
- Rotating sleeve
- Handle-based photographing function ●
- Cable length
- . Image display
- Waterproofness .
- Direction of view ●
- Lens fogging ●
- Image quality
- LED illuminance test .
- LED color temperature test
- Air tightness test .
- Suction ability ●
- Water delivery ability ●
- LED temperature test ●
- . Handle-based camera button reliability test
- field of view test ●
- resolution test ●
- observation depth of field test ●
- geometric distortion test
- SNR test ●
- dynamic tolerance test ●
- brightness uniformity test .
- . color reduction test

#### VIII Conclusion

The Single-Use Flexible Cystoscope is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is safe and effective.